Cytoxan (Oral, Intravenous)

Cyclophosphamide is used to treat cancer of the ovaries, breast, blood and lymph system, and nerves (mainly in children). Cyclophosphamide is also used for retinoblastoma (a type of eye cancer mainly in children), multiple myeloma (cancer in the bone marrow), and mycosis fungoides (tumors on the skin). It belongs to a group of cancer medicines called alkylating agents.

Cyclophosphamide is also used for some types of kidney disease.

Cyclophosphamide interferes with the growth of cancer cells, which are then destroyed by the body. Since the growth of normal body cells may also be affected by cyclophosphamide, other effects may occur. Some of these effects can be serious and must be reported to your doctor. Other effects, such as hair loss, may not be serious but could cause concern. Some effects may not appear for months or years after using the medicine.

Before starting treatment with cyclophosphamide, you and your doctor should discuss the benefits of this medicine as well as the risks of using it.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress at regular visits to ensure that this medicine is working properly and to look for unwanted effects.

While you are being treated with cyclophosphamide, and after you stop treatment with it, do not get any immunizations (vaccines) without your doctor's approval. Cyclophosphamide may lower your body's resistance, which could make the vaccine less effective or increase your risk of getting the infection the vaccine is meant to prevent. Additionally, you should not be around others in your household who receive live virus vaccines, as they could potentially pass the virus to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Avoid close contact with them and do not spend a long time in the same room with them. If you have questions about this, talk to your doctor.

Before having any type of surgery, including dental surgery or emergency treatment, make sure the medical doctor or dentist in charge knows that you are taking this medicine, especially if you have taken it within the last 10 days.

Cyclophosphamide may cause temporary hair loss in some people. After treatment has ended, normal hair growth should return, but the new hair may be a slightly different color or texture.

Cyclophosphamide can temporarily lower the number of white blood cells in your blood, which increases the chance of getting an infection. It can also lower the number of platelets needed for proper blood clotting. If this happens, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If possible, avoid people with infections. Contact your doctor right away if you think you might be getting an infection or if you experience fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Contact your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in your urine or stools; or pinpoint red spots on your skin.
• Be cautious when using a regular toothbrush, dental floss, or toothpick. Your doctor, dentist, or nurse may suggest other ways to clean your teeth and gums. Check with your doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when using sharp objects like a safety razor or nail clippers.
• Avoid contact sports or other activities where bruising or injury could happen.

Before you have any medical tests, inform the medical doctor in charge that you are taking this medicine. The results of some tests may be impacted by this medicine.

In deciding to use a medicine, your doctor will help you weigh the risks against the benefits. Here are some important points to consider for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

This medicine has been tested in children and has not been shown to cause different side effects or problems compared to adults.

Geriatric

Many medicines have not been specifically studied in older adults. Therefore, it may not be clear if they work the same way in older people as they do in younger adults. Although there is no specific information comparing the use of cyclophosphamide in the elderly with other age groups, it is not expected to cause different side effects or problems in older people than in younger adults.

Breast Feeding

Studies in breastfeeding women have shown harmful effects on infants. An alternative medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below when you are using this medicine. The following interactions are significant but may not be all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Varicella Virus Vaccine, Live
• Zoster Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of use for one or both medicines.

• Abametapir
• Adenovirus Vaccine
• Amprenavir
• Atazanavir
• Bacillus of Calmette and Guerin Vaccine, Live
• Boceprevir
• Carbamazepine
• Ceritinib
• Cholera Vaccine, Live
• Cobicistat
• Cyclosporine
• Darunavir
• Dengue Tetravalent Vaccine, Live
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Eslicarbazepine Acetate
• Etanercept
• Fexinidazole
• Fosamprenavir
• Fosphenytoin
• Idarubicin
• Indinavir
• Influenza Virus Vaccine, Live
• Lemborexant
• Lopinavir
• Nelfinavir
• Nevirapine
• Nilotinib
• Pentostatin
• Phenobarbital
• Phenytoin
• Poliovirus Vaccine, Live
• Primidone
• Ritonavir
• Ruxolitinib
• Saquinavir
• Smallpox Vaccine
• Sparsentan
• St John's Wort
• Tamoxifen
• Telaprevir
• Tipranavir
• Typhoid Vaccine, Live
• Warfarin
• Yellow Fever Vaccine

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both medications may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or frequency of use for one or both medicines.

• Ondansetron
• Thiotepa

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used close to the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you use this medicine. Make sure to tell your doctor if you have any other medical issues, especially:

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body.

• Gout, history of or
• Kidney stones, history of—Cyclophosphamide may raise uric acid levels in the body, which can lead to gout or kidney stones.

• Infection—May reduce the body's ability to fight infections.

• Kidney disease—The effects of cyclophosphamide may be stronger because of slower removal from the body.

• Liver disease—The effects of cyclophosphamide may be weaker.

• Prior removal of adrenal gland(s)—Toxic effects of cyclophosphamide may be increased, and dosage adjustment may be needed.

• Tumor cell accumulation—Higher risk of tumor cells entering the bone marrow due to bone marrow suppression from high doses of cyclophosphamide.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Cough or hoarseness
• Fever or chills
• Lower back or side pain
• Missing menstrual periods
• Painful or difficult urination

With high doses and/or long-term treatment

• Blood in the urine
• Dizziness, confusion, or agitation
• Fast heartbeat
• Joint pain
• Shortness of breath
• Swelling of the feet or lower legs
• Unusual tiredness or weakness

Less common

• Black, tarry stools
• Pinpoint red spots on the skin
• Unusual bleeding or bruising

Rare

• Frequent urination
• Redness, swelling, or pain at the injection site
• Sores in the mouth and on the lips
• Sudden shortness of breath
• Unusual thirst
• Yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Darkening of the skin and fingernails
• Loss of appetite
• Nausea or vomiting

Less common

• Diarrhea
• Flushing or redness of the face
• Headache
• Increased sweating
• Skin rash, hives, or itching
• Stomach pain
• Swollen lips

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Cytoxan
• Cytoxan Lyophilized

Available Dosage Forms:

• Capsule
• Powder for Solution
• Tablet
• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Alkylating Agent

Chemical Class: Nitrogen Mustard

Take this medicine only as directed by your doctor. Do not take more or less of it, and do not take it more often than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Taking too much may increase the chance of side effects, while taking too little may not improve your condition.

Cyclophosphamide is sometimes given together with certain other medicines. If you are using a combination of medicines, make sure that you take each one at the proper time and do not mix them. Ask your doctor to help you plan a way to remember to take your medicines at the right times.

While you are using cyclophosphamide, it is important that you drink extra fluids so that you will pass more urine. Also, empty your bladder frequently, including at least once during the night. This will help prevent kidney and bladder problems and keep your kidneys working well. Cyclophosphamide passes from the body in the urine. If too much of it appears in the urine or if the urine stays in the bladder too long, it can cause dangerous irritation. Follow your doctor's instructions carefully about how much fluid to drink every day. Some patients may have to drink up to 7 to 12 cups (3 quarts) of fluid a day.

Usually it is best to take cyclophosphamide first thing in the morning, to reduce the risk of bladder problems. However, your doctor may want you to take it with food in smaller doses over the day, to lessen stomach upset or help the medicine work better. Follow your doctor's instructions carefully about when to take cyclophosphamide.

Cyclophosphamide often causes nausea, vomiting, and loss of appetite. However, it is very important that you continue to use the medicine even if you begin to feel ill. Do not stop taking this medicine without first checking with your doctor. Ask your doctor for ways to lessen these effects.

If you vomit shortly after taking a dose of cyclophosphamide, check with your doctor. You will be told whether to take the dose again or to wait until the next scheduled dose.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):For the treatment of cancer: Adults—Dose is based on body weight and must be determined by your doctor. The usual dose is 1 to 5 milligrams (mg) per kilogram (kg) of body weight per day. Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 1 to 5 mg per kg of body weight per day.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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